Michael Lincoff
Chief Clinical Officer, Canary Cure & Ex Chair, Cardiovascular & Renal Drugs Advisory Committee, Canary Cure Therapeutics
Seminars
- Prioritizing the resolution of co-morbidities such as MASH, CKD, and heart failure to move beyond BMI reduction as the sole metric of clinical success, establishing obesity drugs as essential “foundation therapies” for lifelong cardiometabolic protection
- Implementing evidence-based “step-down” protocols, transitioning patients from high-dose injectable peptides to low-dose oral small molecules or RNA-based silencers to suppress the biological “rebound effect” after reaching goal weight for durable weight stability and higher long-term therapy persistence
- Integrating longitudinal data on physical function, hospitalization rates, and employment status to quantify the total economic value of long-term obesity treatment, providing a robust scientific justification for expanded reimbursement and universal patient access across diverse socioeconomic populations
This intensive workshop will delve into the critical shift from traditional BMI-centric metrics to a more sophisticated regulatory framework that reflects the true biological impact of next-generation obesity therapeutics.
As the FDA moves toward evaluating “quality of weight loss” and metabolic improvement, this session provides a strategic toolkit for biotechs to align their clinical endpoints with modern regulatory expectations. Central to this evolution is the Lancet Commission’s new framework, which offers a structured 18-point system to assess tissue and organ dysfunction. By differentiating between Pre-clinical obesity (excess adiposity without dysfunction) and Clinical obesity (impaired organ function), this framework allows for more precise patient stratification and offers a method to prioritize pharmacological or surgical interventions for those with the highest biological risk.
This session will cover:
- Integrating advanced body composition metrics to move beyond the limitations of the scale, utilizing DEXA and MRI data to quantify changes in visceral adipose tissue and lean muscle mass as primary or key secondary endpoints
- Defining meaningful metabolic endpoints by establishing validated links between drug-induced weight loss and the resolution of comorbidities such as MASH, CKD, and heart failure to support “beyond weight loss” label claims
- Designing trials for functional outcomes that measure improvements in physical mobility, exercise capacity, and respiratory function, providing the FDA with clear evidence of enhanced patient quality of life
- Navigating the regulatory path for maintenance and prevention by developing trial structures that satisfy FDA requirements for long-term safety and weight-regain prevention
- Establishing collaborative regulatory strategies for novel mechanisms (such as gene therapies or non-incretins) where traditional weight-loss benchmarks may not fully capture the drug’s therapeutic value
